A randomized, double-blind, placebo-controlled Phase 3 study of SGN-35 (brentuximab vedotin) and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT)
- Conditions
- Hodgkin lymphoma (HL)MedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-016947-20-BG
- Lead Sponsor
- Seattle Genetics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 322
1. Patients with HL who have received ASCT in the previous 30–45 days.
2. Patients at high risk of residual HL post ASCT
3. Histologically-confirmed classical HL, which excludes NLPHL.
4. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 311
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
1. Previous treatment with brentuximab vedotin.
2. Previously received an allogeneic transplant.
3. Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT.
4. History of another primary malignancy that has not been in remission for at least 3 years.
5. Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents.
6. Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy (PML).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to compare the progression-free survival (PFS) of SGN-35 and best supportive care (BSC) versus placebo and BSC.;Secondary Objective: The secondary objectives are:<br>• To compare overall survival (OS) between the 2 treatment arms<br>• To evaluate the safety and tolerability of SGN-35 compared to placebo<br>• To characterize the incidence of anti-therapeutic antibodies (ATA)<br><br>;Primary end point(s): The primary efficacy endpoint of this study is progression-free survival (PFS) per an independent review facility (IRF).<br><br>;Timepoint(s) of evaluation of this end point: Every 3-6 months until disease progression or study closure
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary efficacy endpoint is overall survival (OS);Timepoint(s) of evaluation of this end point: Every 3-6 months until study closure